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Volume X, Number 331


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FDA Requests Comments on Labeling Cell-Cultured Seafood Products

On October 7, the U.S. Food and Drug Administration (FDA) published a request for comment on proposed labeling for cell-cultured seafood products. 85 FR 63277 (Oct. 7, 2020). Stakeholders now have an opportunity to comment on how these novel food products should be labeled, including appropriate descriptors for a product’s name, nature, source, and characteristics.

“Cell-cultured” refers to the process by which the seafood is created, in a sterile laboratory environment from the cells of a living or recently slaughtered animal. These cells are duplicated and harvested into products that mimic the taste, texture, and aesthetics of conventional seafood. The principal driver behind FDA’s request is to avoid misbranding of cell-cultured seafood products. The Federal Food, Drug and Cosmetic Act (FFDCA) prohibits the offering of food for sale under the name or label of another food, and FDA has acknowledged that consumers may not understand that “cultured seafood” is distinct from conventionally harvested seafood.  Simply put, FDA is legally required to ensure that food is accurately described on its label, and that non-standardized foods are labeled with terms that consumers can understand.

FDA suggested that there are no common usages of the term “cultured seafood” yet, and is inviting commenters to provide any evidence to the contrary. FDA has also asked for feedback on whether labeling should give details about the novel production method associated with these products. To that end, FDA requested input on the descriptor “cultured,” as consumers may be familiar with the term “aquaculture,” but not “cell-cultured production.” Commenters are also invited to explain why possible alternative terms may better describe the product (i.e., “cell cultured,” “cell-based,” or “cell-cultivated”).

FDA also asked whether labels should include a cell-cultured product’s type or cut – for example, fillet or steak – or other attributes like its taste, texture, aroma, or nutrition, if they differ from conventional seafood.

Comments may be submitted until March 8, 2021.

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 296



About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

Sarah A. Kettenmann Environmental Attorney Beveridge & Diamond New York, NY

Sarah uses her knowledge of environmental law and the physical sciences to help clients solve complex problems in a conservation-minded manner.

She maintains a diverse environmental practice, which includes litigation matters involving toxic torts and products liability and class action litigation concerning environmental and regulatory claims. Her regulatory practice includes advising clients on compliance with, and enforcement of, land use restrictions and remediation, and due diligence for waste facility permits under federal and state statutes. She also counsels clients on...